Abstract: A device for treating a tissue region at or near a sphincter including a proximal support, a distal support and an expandable basket having a plurality of spines. The spines have a proximal portion, a distal portion and an intermediate portion therebetween, wherein the spines are movable from a first non-expanded position to a second expanded position wherein in the expanded position the intermediate portion of the spines extends outwardly radially beyond the proximal and distal portions of the spines. A plurality of electrodes are carried by the spines and movable outwardly to an outward position to penetrate tissue for application of energy to the tissue region.

Abstract: A method of regulating temperature at a tissue site comprising measuring sphincter tissue temperature at or near a tissue site, comparing the measured sphincter tissue temperature to a desired temperature, increasing an existing flow rate of a cooling solution to the tissue site if the measured tissue temperature exceeds the desired temperature, and maintaining the existing flow rate of the cooling solution to the tissue site if the measured temperature does not exceed the desired temperature.

Abstract: A device for treating a tissue region is supplied with a separate usage key card. The usage key card comprises a storage medium, which is formatted to contain an identification code unique to the usage key card. The usage key card is adapted to be read by a remote reader, to download the identification code for processing by a controller for the device. Processing of the identification code by the controller either enables or disables operation of the device according to prescribed criteria. A viewable image is generated on a display screen that changes in response to processing of the identification code.

Abstract: Improved devices, systems and methods for treating a tissue region provide straightforward, yet reliable ways for installing diverse functional components within the confined space of a catheter-based instrument.

Abstract: Improved devices, systems and methods for treating a tissue region provide straightforward, yet reliable ways for installing diverse functional components within the confined space of a catheter-based instrument.

Abstract: A family of barrel structures is provided in a kit. Each barrel structure is differently sized and configured for advancement into anal canals of different anatomic morphologies. Instructions are provided for using the barrel structures to treat an individual. The instructions instruct assessing an anatomic morphology of an anal canal of an individual to be treated and selecting one of the barrel structures based upon the assessed anatomic morphology. Each barrel structure carries an electrode sized and configured to be coupled to a source of tissue ablation energy to be applied through the electrode to form a lesion. Each barrel structure includes a transparent side wall visualized by a direct line of sight from an end portion of the first barrel structure. The instructions instruct inserting the selected barrel structure into the anal canal and visualizing by the direct line of sight through the transparent side wall of the selected barrel structure the dentate line and the targeted tissue region.

Abstract: Systems and methods deploy an electrode from a catheter assembly. The systems and methods provide a catheter handle having a trigger lever adapted to carry an actuator rod. The actuator rod is adapted to cause movement of the electrode between a retracted position and an extended position. A pinion is carried by the trigger lever for engagement with a rack carried by the actuator rod. Compression of the trigger lever moves the rack along the actuator rod between a first position corresponding to the electrodes being in the retracted position and a second position corresponding to either the primed electrode firing position or the electrodes being in an extended position.

Abstract: Improved devices, systems and methods for treating a tissue region provide straightforward, yet reliable ways for installing diverse functional components within the confined space of a catheter-based instrument.

Abstract: Systems and methods are provided for positioning and stabilizing an external instrument during insertion of the instrument through the oral cavity (e.g., insertion of a catheter through the oral cavity and into the esophagus or cardia for treatment of gastroesophageal reflux disease (GERD)). The systems and methods provide a gripping tool for association with a bite block, capable of selectively moving between an open position in which the instrument may be inserted or removed, and a closed position in which the external instrument is held in a fixed position.

Abstract: A family of barrel structures is provided in a kit. Each barrel structure is differently sized and configured for advancement into anal canals of different anatomic morphologies. Instructions are provided for using the barrel structures to treat an individual. The instructions instruct assessing an anatomic morphology of an anal canal of an individual to be treated and selecting one of the barrel structures based upon the assessed anatomic morphology. Each barrel structure carries an electrode sized and configured to be coupled to a source of tissue ablation energy to be applied through the electrode to form a lesion. Each barrel structure includes a transparent side wall visualized by a direct line of sight from an end portion of the first barrel structure. The instructions instruct inserting the selected barrel structure into the anal canal and visualizing by the direct line of sight through the transparent side wall of the selected barrel structure the dentate line and the targeted tissue region.

Abstract: Improved devices, systems and methods for treating a tissue region provide straightforward, yet reliable ways for installing diverse functional components within the confined space of a catheter-based instrument. Methods include providing a manifold body sized to fit within a catheter tube, the manifold body including a single main fluid junction, multiple branch fluid junctions, and a fluid circuit formed within the manifold body to channel fluid flow between the single main fluid junction and the multiple branch fluid junctions, coupling the single main fluid junction to a fluid source or a fluid destination external to the catheter tube, coupling each of the multiple branch fluid junctions individually to a fluid-conveying port on the operative element, and mounting the manifold within the catheter tube.

Abstract: A surgical apparatus having an expandable structure including first, second and third spines forming a basket, movable between expanded and contracted positions. Each of the spines has first, second and third lumens, wherein an electrode element is movable within the first lumen of the first, second and third spines through a first opening in the spine. The second lumen of the first and second spines carries a temperature sensing element, the temperature sensing element exposed through a second opening in the spine positioned between the first and second lumens. The second lumen of the third spine is configured to receive a guidewire, and the third lumen of the first, second and third spines is connectable to a tube for carrying cooling fluid therethrough.

Abstract: An apparatus treats tissue at or near a sphincter. The apparatus has an elongated member having at least one lumen including an inflation lumen, and a basket assembly including a first and a second arm. An inflatable member is coupled to the inflation lumen and has a deployed and a non-deployed state. In the deployed state, the inflatable member expands the basket assembly into contact with tissue. At least one of the first and second arms of the basket assembly has a fluid lumen having an aperture for conveying a fluid from the basket assembly. A source of fluid is coupled to the fluid lumen for conveyance of fluid through the aperture. The fluid can be, e.g., an electrolytic solution, and/or an anti-infection agent, and/or an echogenic media, and/or a steroid, and/or an anesthetic, and/or a medicament, and/or a tissue cooling agent. The source can be a drug delivery device.

Abstract: A device for treating a tissue region at or near a sphincter including a proximal support, a distal support and an expandable basket having a plurality of spines. The spines have a proximal portion, a distal portion and an intermediate portion therebetween, wherein the spines are movable from a first non-expanded position to a second expanded position wherein in the expanded position the intermediate portion of the spines extends outwardly radially beyond the proximal and distal portions of the spines. A plurality of electrodes are carried by the spines and movable outwardly to an outward position to penetrate tissue for application of energy to the tissue region.

Abstract: Systems and methods for treating a tissue region employ an expandable structure projecting beyond the distal end of a catheter tube. A distal tail projects beyond the far end of the basket assembly. The distal tail includes a guidewire lumen that accommodates passage of a guidewire without threading the guidewire through the catheter tube.

Abstract: Systems and methods for treating a tissue region employ an expandable structure projecting beyond the distal end of a catheter tube. A distal tail projects beyond the far end of the basket assembly. The distal tail includes a guidewire lumen that accommodates passage of a guidewire without threading the guidewire through the catheter tube.

Abstract: Systems and methods affect tightening of the pyloric sphincter and/or serve to mediate or moderate receptive relaxation of muscles in the stomach, to treat or mitigate various physiologic conditions, such as obesity, biliary reflex, GERD, and/or Barrett's esophagus. The systems and methods may be used as either a primary treatment modality, or applied as a supplementary treatment before, during or after a primary intervention.

Abstract: Systems and methods are provided for positioning and stabilizing an external instrument during insertion of the instrument through the oral cavity (e.g., insertion of a catheter through the oral cavity and into the esophagus or cardia for treatment of gastroesophageal reflux disease (GERD)). The systems and methods provide a gripping tool for association with a bite block, capable of selectively moving between an open position in which the instrument may be inserted or removed, and a closed position in which the external instrument is held in a fixed position.

Abstract: Systems and methods that treat disorders of the gastrointestinal tract by applying one or more treatment agents to tissue at or near the region where abnormal neurological symptoms or abnormal tissue conditions exist. The treatment agent is selected to either disrupt the abnormal nerve pathways and/or to alleviate the abnormal tissue conditions. The treatment agent can include at least one cytokine and/or at least one vanilloid compound to evoke a desired tissue response. The systems and methods can be used a primary treatment modality, or as a neoadjuvent or adjuvant treatment modality.

Abstract: Systems and methods that treat disorders of the gastrointestinal tract by applying one or more treatment agents to tissue at or near the region where abnormal neurological symptoms or abnormal tissue conditions exist. The treatment agent is selected to either disrupt the abnormal nerve pathways and/or to alleviate the abnormal tissue conditions. The treatment agent can include at least one cytokine and/or at least one vanilloid compound to evoke a desired tissue response. The systems and methods can be used a primary treatment modality, or as a neoadjuvent or adjuvant treatment modality.